Bronchoscope Adapter and Methods for Using the Same

ABSTRACT

Bronchoscope adapters and methods of using the same are provided. Aspects of the adaptors include a body having a passageway, a mechanical ventilator access port, a bronchoscope access port configured to receive a bronchoscope into the passageway, and an exit port. The bronchoscope access port comprises a reversibly adjustable inner diameter component that provides locking of the bronchoscope at desired position. The adaptors find use in a variety of different applications.

CROSS-REFERENCE TO RELATED APPLICATIONS

Pursuant to 35 U.S.C. § 119(e), this application claims priority to thefiling date of U.S. Provisional Application Ser. No. 62/002,081 filedMay 22, 2014, the disclosure of which is herein incorporated byreference.

INTRODUCTION

Bronchoscopy is one of the most common surgical procedures performed bypulmonologists, thoracic surgeons and other trained medicalprofessionals. A fibrotic bronchoscope consists of a long, flexible tubecontaining several elements: an illumination device for the field distalto the tip of bronchoscope; an image-capturing system delivering alive-video feed with the capability of taking still photos, all througha flexible optical fiber connected to an external light source; and aworking channel, via which, both diagnostic and therapeutic instruments,and agents (such as biopsy forceps, aspiration needle, brushes, laser,cryo, radiofrequency probe, fiducial markers, medications, etc.) areinserted or instilled. The distal tip of bronchoscope is steerable onone plane by flipping a lever up and down, and on another plane byrotating the handle of bronchoscope left and right to reach the intendedtargets.

Bronchoscopies are performed routinely in the diagnosis and treatment ofvarious lung diseases such as pulmonary nodule, lung mass, lung cancer,pneumonia, atelectasis, emphysema and foreign body retrieving.Bronchoscopies are usually performed by pulmonologists, thoracicsurgeons, or other trained medical professionals, also known as abronchoscopist.

One of greatest achievements in pulmonary/chest medicine is the recentdevelopment of the electromagnetic navigational bronchoscopy (ENB). TheENB provides tools of high precision in both diagnosis and treatment ofpulmonary nodules and lung cancer. The ENB utilizes computer technologyin digitalizing the collected image data of a patient's lung anatomyacquired from a chest computerized tomography (CT) scan. It thenreconstructs the patient's lung anatomy in a three dimensional model andthrough an electromagnetic field allows for the physician to locate theintended target (e.g. tumor, nodule, etc.). This new technology, theENB, revolutionizes the diagnosis and treatment of certain lungdiseases. It enables physicians to enter a new frontier of human lungspace; it makes it possible to reach peripheral, distal and tiny lesionswith high precision in a minimally invasive way compared to conventionalbronchoscopy; and it replaces other invasive surgical procedures, suchas transthoracic needle biopsy, open lung biopsy, etc.

The nature of the ENB procedure demands high precision, and typicallythe ENB is performed under general anesthesia. It necessitates theintubation of the patient, an insertion of an endotracheal tube insidethe patient's respiratory system while simultaneously placing thepatient inside a defined magnetic field. Currently, the ENB requires aminimum staff of four or more: the bronchoscopist, an anesthesiologist,one or more scrub nurses, and a circulating nurse meant solely for thepurpose of managing documentations.

During a typical ENB procedure after a patient is intubated and fullyanesthetized, the bronchoscopist inserts the bronchoscope into theendotracheal tube via an adapter of three ports, one port for thebronchoscope, one port for the mechanical ventilator, and an exit portfor connection to a tracheal tube, e.g., an endotracheal tube. Examplesof such adaptors are described in various United States patents,including U.S. Pat. No. 5,158,569 to Strickland, et al.; U.S. Pat. No.4,683,879 to Tudor; U.S. Pat. No. 4,416,273 to Grimes, et al. Afterinsertion, the procedure moves onto an examination of the generalstructures of the lungs. Navigation through the lung space is achievedby movement of the bronchoscope handle. The bronchoscope can be pulledup, pushed down, rotated left and right, and flipped by a deflectionlever up and down, eventually driving the bronchoscope to the intendedtarget(s). Once the bronchoscope tip reaches its furthest point (eitherlimited by the diameter of the patient's bronchial tree and/or the angleof the bronchial tree branch), an extended working channel/catheter(EWC) along with locatable guide (LG) in place is introduced through thebronchoscope work channel. This EWC and LG have much smaller diametersand far more flexible tips, allowing the physician to overcome the sizeand angular limitations of the bronchoscope. The EWC and LG extend thephysician's reach to the much more distal portions of the bronchial treeand its smaller lesions where the target of interest typically resides.This predetermined navigational path is chosen by a combination ofcomputer software and the expertise of the bronchoscopist. Thenavigation is accomplished by viewing both live and visual images in athree-dimensional space. Once the tip of LG reaches its intended target,the LG is removed and the tools of choice (biopsy forceps, aspirationneedle, needle brush, fiducial or such), will be inserted through theEWC to accomplish intended tasks (such as a biopsies of the lesion orthe placement of the fiducial, etc.). The EWC is being held steady andlocked at the orifice of the working channel on the bronchoscope byexisting devices and methods, such as described in “System ofaccessories for use with bronchoscope” to Greenberg, Bet al., USPO U.S.Pat. No. 8,663,088; USPO U.S. Pat. No. 8,317,149 to Greenburg B. et al.and PCT patent application no, WO 03/086498 entitled “EndoscopeStructure and Techniques for Navigation in Branched Structure” toGilboa.

SUMMARY

Bronchoscope adapters and methods of using the same are provided.Aspects of the adaptors include a body having a passageway, a mechanicalventilator access port, a bronchoscope access port configured to receivea bronchoscope into the passageway, and an exit port configured toconnect to an endotracheal tube. The bronchoscope access port comprisesa reversibly adjustable inner diameter component. The adaptors find usein a variety of different applications.

The current invention compliments and completes the existingapplications, such as described in the introduction section above, toachieve a complete control and lock down of a bronchoscope along with anEWC at the intended target position by a single operator, i.e., thebronchoscopist. While the current devices and methods described byGilboa and Greenburg are able to lock the EWC with/on bronchoscope, thebronchoscope itself still remains a moving object, due to therespiration of the patient, the respiration of the bronchoscopist andthe repeated maneuvers at the orifice of the EWC; such as changes ofinstruments, repeated sampling. All these disturbances displace the EWCtip several millimeters or even centimeters away from the intendedtarget due to the subtle moving up and down of the bronchoscopealong/relative to the endotracheal tube. This undesired and inevitablemovement of bronchoscope relative to the endotracheal tube with theexisting devices, could move the EWC tip far away from the intendedtarget, and completely negates the tremendous effort made to navigate toand then lock the EWC tip at the intended target. This undesiredmovement causes several problems: missing the target without awarenessof operator, resulting in poor precision leading to reduction of thediagnostic yield, or requiring repeated navigation to the same target,increasing in the operational time. This intrinsic imperfection ofexisting devices is currently remedied by requiring additional personnelto hold the bronchoscope at the junction of endotracheal tubeperiodically.

The existing practice increases the complexity of an already complicatedmulti- person procedure that requires delicate coordination between thebronchoscopist and the assistants. Current conditions greatly add to thecost of the operation and more so, often result in missing the intendedtargets of the procedure that depend on the high precision of theoperators.

The current invention, the device and its mechanisms described here,allow for the adjustable locking of the bronchoscope to the endotrachealtube. Embodiments of the invention provide and maintain an airtightsealing of the ventilator system, reduce additional personnel, and givethe bronchoscopist total control of navigation, targeting, locking andadjusting the bronchoscope as desired. Embodiments of the inventionfacilitate and secure the locking of the EWC tip to the intended targetleading to greater precision in accomplishing the intended tasks.Embodiments of the current invention also expand and accommodate varioussize ranges of bronchoscopes as compared with current adapters.Embodiments of the current invention, in combination of existing ENBtechnology, add a new arsenal in the field of the diagnosis andtreatment of pulmonary nodules, particularly early lung cancer.Furthermore, embodiments of the invention aid in the reduction of humanerror, increase the precision of the bronchoscopic surgical procedures,improve the diagnostic yield of bronchoscopic biopsies, deliver anytherapeutic modality, such as fiducial, laser to a more precise targetlocation, and greatly reduce the existing operation cost.

Aspects of the invention include an apparatus and related mechanisms,which secure a bronchoscope at a desired position of choice, and allowfor the adjustment and security at new positions at will through asingle operator, i.e., the bronchoscopist, and further facilitate thesecuring of EWC or such at target position as intended.

Adaptors according to embodiments of the invention are configured toprotect the delicacy of the fiber optic material used in the flexiblefiber optic bronchoscope, while providing secure locking of thebronchoscope. The locking is adjustable and controlled by singleoperator, the bronchoscopist, and achieved by providing a direct contactof the delicate bronchoscope only with an elastomeric material, such aspolymeric material, e.g., a silicone or thermoplastic elastomer (TPE)material. The locking mechanism is accomplished through the manipulationof a cylindrical conduit of the elastomeric material, caused by verticalforce controlled by the bronchoscopist.

Embodiments of the current invention are configured to maintain theintegrity of the airtight ventilator system while bronchoscopic surgicalprocedures are being performed. Because of the adjustable nature of thecurrent invention, the size range of bronchoscopes able to be used witha single adaptor is greatly expanded, allowing for smaller pediatricbronchoscopes to be employed with an adaptor also configured to be usedwith adult sized bronchoscopes.

Embodiments of the current invention provide for the substitution ofpersonnel currently required, to reduce human error, and to streamlinethe complicated operation. By doing so, embodiments of the currentinvention significantly reduce the cost of bronchoscopic procedures,e.g., as compared to existing practice.

Embodiments of the current invention provide for an airtight ventilatorsystem at the end of bronchoscopic intervention, by simply plugging thebronchoscope access port using the attached plug at the end of procedurewhen the bronchoscope is removed from the endotracheal tube, before thepatient is successfully extubated. Embodiments of the current inventionsignificantly increase the precision and accuracy of the intendedoperation-leading to higher diagnostic yields, better therapeuticresults through reduction of the variables of human error. Embodimentsof the current invention expand the arsenal of tools available to thehealth care professional in the field of diagnosis and treatment ofpulmonary nodule, particularly early lung cancer.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 to 6 depict various views of a device according to an embodimentof the invention.

DETAILED DESCRIPTION

Bronchoscope adapters and methods of using the same are provided.Aspects of the adaptors include a body having a passageway, a mechanicalventilator access port, a bronchoscope access port configured to receivea bronchoscope into the passageway, and an exit port configured toconnect to an endotracheal tube. The bronchoscope access port comprisesa reversibly adjustable inner diameter component. The adaptors find usein a variety of different applications.

Before the present invention is described in greater detail, it is to beunderstood that this invention is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Certain ranges are presented herein with numerical values being precededby the term “about.” The term “about” is used herein to provide literalsupport for the exact number that it precedes, as well as a number thatis near to or approximately the number that the term precedes. Indetermining whether a number is near to or approximately a specificallyrecited number, the near or approximating un-recited number may be anumber which, in the context in which it is presented, provides thesubstantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

Bronchoscopy Adaptors

As summarized above, aspects of the invention include abronchoscopy/mechanical ventilation adaptor. The adaptor is a devicethat may be viewed as a manifold configured to operationally combine amechanical ventilator, a bronchoscope and a tracheal tube when theseelements are employed in a bronchoscopic procedure. Adaptors asdescribed herein include an elongated body having an internalpassageway. The adaptors are dimensioned to be placed on an endotrachealtube that has been placed in the oral cavity of a mammal, such as ahuman. In some instances, the adaptors have a length ranging from 40 mmto 50 mm, and a width ranging from 35 mm to 55 mm. While thecross-sectional shape of the adaptors may vary, e.g., ranging fromsquare to rectangular to triangular to curvilinear, e.g., circular, insome embodiments the adaptors are tubular in structure. Where theadaptors are tubular in structure, the inner and outer diameters of theadaptors may vary. In some instances, the tubular adaptors have an outerdiameter ranging from 12 mm to 25 mm; and an inner diameter ranging from9 mm to 15 mm. Of course, the dimensions, e.g., inner and/or outerdiameters, may vary or be constant in a given adaptor, as desired.

Adaptors of the invention include a bronchoscope access port configuredto receive a bronchoscope into the passageway of the adaptor. Thebronchoscope access port may be positioned on the body at any convenientlocation, and in certain embodiments is positioned at one end of thebody, e.g., the proximal end of the body of the adaptor. Thebronchoscope access port has an inner diameter that is configured toprovide access of a bronchoscope into the passageway of the adaptor.While the inner diameter of the bronchoscope access port may vary, insome instances the inner diameter ranges from 3.5 mm to 7 mm, such as 4to 7 mm. The bronchoscope access port may have a length that varies,ranging in some instances from 10 to 20 mm. While the angle of thelongitudinal axis relative to the longitudinal access of the passagewaymay vary, in some instances ranging from 0 to 15°, in some instances thelongitudinal axis of the bronchoscope access port is coaxial with thelongitudinal access of the passageway.

Aspects of the adaptors described herein include a reversibly adjustableinner diameter component associated with the bronchoscope access port. Areversibly adjustable inner diameter component is a sub-device of theadaptor that is configured to provide for a reversible change in theinner diameter of the bronchoscope access port. As the change in theinner diameter is reversible, it can be adjusted as desired toaccommodate the size of the bronchoscope being used with the adaptor,e.g., to provide a sealing relationship with the bronchoscope and yetnot damage the bronchoscope. The reversibly adjustable inner diametercomponent may be configured to provide a variety of inner diameters, andin some instances is configured to provide a magnitude of diameterchange between its most open and most constricted settings that ranges 1to 3.5 mm, such as 1 to 3.5 mm. The reversibly adjustable inner diametermay be configured to provide for a variety of different inner diametersin the access port, and in some instances has an adjustable diameterthat ranges from 4 to 8 mm, such as 3.5 to 7 mm.

The bronchoscope access port comprises may include an actuator that isconfigured to provide for mechanical adjustment of the reversiblyadjustable inner diameter component. Any convenient actuator may bepresent, so long as it provides for adjustment of the inner diameter ofthe adjustable component, as desired. An example of an actuator ofinterest is a compressible member that may be turned in a manner thatchanges the inner diameter of the adjustable component. In someinstances the compressible member, e.g., in the form of a knob or dial,is configured to deform about the longitudinal axis of the bronchoscopeaccess port along a thread so that it moves along the longitudinal axisof the access port and, in doing so, compresses a compressible member,e.g., as described in greater detail below.

The adjustable inner diameter component may include a compressiblemember configured so that the compression of the compressible memberresults in a decrease in the inner diameter of the adjustable component.While such a compressible member may have a variety of configurations,in some instances it is configured as a tubular member that rests insideof and is coaxial with the longitudinal axis of the access port. Whenthe compressible member is a tubular member, the dimensions of thecompressible member may vary in the compressed and uncompressed states.In some instances, the compressible member in the uncompressed state hasa height ranging from 5 to 10 mm, an inner diameter ranging from 5 to 8mm, such as 3.5 to 7 mm, and an outer diameter that remains constant dueto the hard casing enclosing the compressible member. An example of areversibly adjustable inner diameter component is such a compressiblewhich is operatively coupled or even structurally embedded to arotatable member, e.g., dial, where rotation of the dial, e.g., along asuitable thread, causes the dial to compress or un-compress thecompressible member.

The compressible member of such embodiments may be fabricated from anyconvenient materials. Materials of interest include elastomericmaterials, i.e., materials that are able to resume their original shapewhen a deforming force is removed. Materials of interest include, butare not limited to, polymeric materials, such as naturally occurring orsynthetic rubbers, thermoplastic elastomer (TPE), silicones, etc.

In some instances, the bronchoscope access port may include a sealingmechanism that is configured to seal the access port and passage wayconnected thereto from the outside environment when a bronchoscope isnot present in the access port. The sealing mechanism may vary, and insome instances is configured to provide an airtight seal. Sealingmechanisms of interest include, but are not limited to: plugs, valves,etc., where the sealing mechanism may conveniently be attached to theadaptor whether or not it is sealing the port, if desired.

In addition to the bronchoscope access port, e.g., as described above,adaptors of the invention include a mechanical ventilator access portconfigured to operatively couple a mechanical ventilator to thepassageway of the adaptor. The configuration of the mechanicalventilator access port may vary, so long as it can operatively couple amechanical ventilator tube to the passageway of the adaptor, e.g.,provide for gaseous communication between the interior of the ventilatortube and the passageway of the adaptor. The location of the mechanicalventilator access port may vary on the device, and in some instances islocated between the proximal and distal end, e.g., within 15 to 20 mm ofthe proximal end. In some instances, the mechanical ventilator accessport has an inner diameter ranging from 5 to 10 mm, such as 9 to 10 mm.The mechanical ventilator access port may have a length that varies,ranging in some instances from 20 to 25 mm. While the angle of thelongitudinal axis of the mechanical ventilator access port relative tothe longitudinal access of the passageway may vary, in some instancesranging from 90 to 145, such as 100 to 110°, in some instances thelongitudinal axis of the mechanical ventilator access port is orthogonalto the longitudinal access of the passageway. The mechanical ventilatoraccess port may include an attachment element configured to stablyassociate a ventilator tube with the adaptor, e.g., rotatable in asealing relationship.

Adaptors of the invention further include an exit port configured tooperatively connect the passageway to an endotracheal tube. Theconfiguration of the exit port may vary, so long as it can operativelycouple the endotracheal tube to the passageway of the adaptor, e.g.,provide for gaseous communication between the passageway of the adaptorand the endotracheal tube and rotatable around the endotracheal tube.The location of the exit port may vary on the device, and in someinstances is located at an end of the adaptor, e.g., the distal end. Insome instances, the exit port has an inner diameter ranging from 10 to15, such as 12 to 15 mm. The exit port may have a length that varies,ranging in some instances from 15 to 20 mm. While the angle of thelongitudinal axis of the exit port relative to the longitudinal accessof the passageway may vary, in some instances ranging from 0 to 15°, insome instances the longitudinal axis of the exit port is coaxial withthe longitudinal access of the passageway. The exit port may include anattachment element configured to stably associate a tracheal tube withthe adaptor, e.g., in a sealing relationship. The adaptor may beconfigured to be used with a variety of tracheal tubes, including butnot limited to: an endotracheal tube, a tracheostomy tube, etc.

The adaptor may be fabricated from any convenient material. Suitablematerials include, but are not limited to: medical grade plastics,thermoplastic elastomer (TPE) or silicones, as well as metals. In someinstances, the adaptor is configured as a one time use adaptor, wherethe material is from which it is fabricated is chosen in terms ofsuitability for placement close to the oral cavity and outside body (invitro) of a patient and yet be inexpensive enough to provide for onetime use.

The adaptor is a sterile single-use disposable device. Any other similarsystem using different material and techniques for attaching and lockingbronchoscope to endotracheal tube to achieve the similar goal also fallswithin the scope and spirit of the current invention. Although thecurrent invention is described in the context of electromagneticnavigational bronchoscopy (ENB) in conjunction with mechanicventilation, endotracheal tube, it applies to any other applicationsusing a bronchoscope with or without involved in endotracheal tuberequiring locking the bronchoscope at an adjustable, desired position.

The adaptor having been generally described above, a detaileddescription of an adaptor according to the embodiment shown in FIG. 1 toFIG. 6 is now provided. It is to be understood that the embodimentsshown in FIG. 1 is merely exemplary of the invention which may beembodied in various forms, size using different material. Therefore, thestructure and functional specifics, details presented here are not to beinterpreted as limiting and excluding, but merely as the basis for theclaims, and as representative basis, while the spirit of the currentinvention could be employed in various forms and shapes, withappropriate structure details.

As shown in the FIG. 1 to FIG. 6, the depicted multifunctionalbronchoscope/endotracheal tube adapter/manifold is a cylindrical,tubular body, having three ports, i.e., port A, port B and port C. PortB, which is the ventilator port, is at a substantially angularrelationship to the longitude body, with outer swivel connectingventilator machine (not shown). As depicted in FIG. 1, port B includes aone way snap on swivel 6 and ventilator tubing access 7. Port C, whichis an endotracheal tube port, includes an inner swivel snap on piece 9containing an O-ring 8 (as shown in FIG. 4) for seal, connecting anendotracheal tube via access 10 (ETT shown FIG. 5). Port A is thebronchoscope access port. Port A has rigid housing, in which resides anelastomeric, cylindrical compressible member 4 (made of silicone orthermoplastic elastomer TPE) with a through hole fitting various sizesof bronchoscopes. The locking and accommodating mechanism isaccomplished through changing this through hole inner diameter bydeformation of this silicone/TPE piece 4. Deformation of the piece 4produces circular pressure against bronchoscope, so to lock it atdesired the position. The deformation, i.e., the inner diameter, isadjusted by applying and releasing the vertical force from a cylindricalcap/dial 1 containing a through channel, by screwing or torqueing thecap up and down along the thread 3 (FIG. 4). The through channel 2 onthe access port can be plugged before or after the bronchoscopicprocedures using a removable plug 5, in order to maintain the integrityof ventilator circuit.

Methods of Use

Also provided are methods of using adaptors in bronchoscopic procedures,e.g., as described generally above and exemplified in the experimentalsection, below. In methods of invention, and adaptor having abronchoscope access port with an adjustable inner diameter component,e.g., as described above, is operatively associated with a tracheal tubethat intubates a patient, as well as a mechanical ventilator tube, suchthat the mechanical ventilator tube is operatively connected to thetracheal tube via the passageway of the adaptor. As desired, abronchoscope may be introduced into the passageway and then the trachealtube through the bronchoscope access port, e.g., after removal of asealing element (such as a plug) from the bronchoscope access port. Whendesired, the inner diameter of the adjustable inner diameter componentmay be narrowed, e.g., through compression, to stably associate thebronchoscope with the adaptor, such that the two components do not moverelative to other. After any bronchoscope procedure, the inner diametermay be broadened, e.g., through decompression, to release thebronchoscope such that it may be moved with ease relative to theadaptor.

The subject adaptors and methods may be used in a variety of subjects,including humans, e.g., as described above. In certain embodiments, thesubjects or patients are humans, ranging from neonates to adults.

Kits

As summarized above, also provided are kits for use in practicing thesubject methods. The kits at least include an adaptor, e.g., asdescribed above. The kits may include one or more additional componentsthat may find use in an application where the adaptor is employed, wheresuch additional components include, but are not limited to: extra plugs.The adaptor (and other components when present) of the kits may bepresent in a suitable container, such as a sterile container, e.g., asterile pouch.

In addition to the above components, the subject kits may furtherinclude (in certain embodiments) instructions for practicing the subjectmethods. These instructions may be present in the subject kits in avariety of forms, one or more of which may be present in the kit. Oneform in which these instructions may be present is as printedinformation on a suitable medium or substrate, e.g., a piece or piecesof paper on which the information is printed, in the packaging of thekit, in a package insert, etc. Yet another form of these instructions isa computer readable medium, e.g., diskette, compact disk (CD), HardDrive etc., on which the information has been recorded. Yet another formof these instructions that may be present is a website address which maybe used via the internet to access the information at a removed site.

The following examples are put forth so as to provide those of ordinaryskill in the art with a complete disclosure and description of how tomake and use the present invention, and are not intended to limit thescope of what the inventors regard as their invention nor are theyintended to represent that the experiments below are all or the onlyexperiments performed.

EXPERIMENTAL I. Electromagnetic Navigational Bronchoscopy (ENB)Procedure Using BETLA (Bronchoscope Endotracheal Tube Lock/Adapter)

Patient JD is a 68 years old male with diagnosis of lung nodule/mass,possible early lung cancer. He has two lung nodules, one nodule at rightupper lobe, another one at right middle lobe. A diagnosticelectromagnetic navigational bronchoscopy is performed on JD as follows.After registration, the patient is transferred from the pre-surgicaldepartment to an operating room. An anesthesiologist starts induction ofgeneral anesthesia using either inhaled anesthetics, intravenousanesthetics or both if needed. Once the patient is fully sedated, theanesthesiologist intubates the patient by placing of an endotrachealtube into the patient's trachea and connects the endotracheal tube to amechanical ventilator directly to start mechanical ventilation. Theanesthesiologist secures the endotracheal tube by taping it to thepatient. Throughout the operation process, the patient's respiration isfully provided by a mechanical ventilator and his vital signs aremonitored closely. Once the operation team is ready to start, theanesthesiologist unwraps a single use BETLA, e.g., as depicted inFIG. 1. The anesthesiologist attaches port B, the ventilator port of theBETLA, to a mechanical ventilator. The anesthesiologist attached port C,the endotracheal tube port/connector, to the endotracheal tube, whilekeeping port A, the bronchoscope port of the BETLA, plugged, awaitingthe bronchoscopist to start.

After unplugging port A, a bronchoscopist inserts a bronchoscope intothe endotracheal tube via port A of the BETLA. (Because of the innerdiameter of port A is adjustable, rather than being fixed as in allcurrent analogous adaptors, the BETLA can accommodate various sizes ofbronchoscopes depending on the intended procedures and patients'anatomy). As part of the procedure, the bronchoscopist examines thegeneral structures of patient's lungs, cleans up visible secretions ifany, and takes photos for the record. The bronchoscopist navigates alongthe bronchial tree as if on enclosed highways inside the lung space byperforming a variety of manipulations, such as pulling up, pushing down,rotating left and right of the bronchoscope, and flipping thebronchoscope tip by a deflection of the lever up and down, eventuallydriving the bronchoscope to the nearest point of the intended target(s).The bronchoscopist starts with the right upper lobe lesion, navigates topositions the bronchoscope tip to the nearest point of the intendedtarget(s) according to pre-planned navigational path. This predeterminednavigational path is planned and chosen by combining of computersoftware mapping of airways, targets and the expertise of thebronchoscopist. The navigation process is accomplished with viewing bothlive and visual images in a three-dimensional fashion. Once thebronchoscope tip reaches its furthest point allowed (either limited bythe diameter of the patient's bronchial airway tree and/or the angle ofthe bronchial tree branch), the bronchoscopist introduces an extendedworking channel (EWC) with a locatable guide (LG) in place through thebronchoscope work channel. This EWC and LG have much smaller diametersand far more flexible tips, allowing the bronchoscopist to overcome thesize and angular limitations of the bronchoscope itself. By using theEWC and LG the bronchoscopist reaches to the smaller, more distalportions of the bronchial tree where the target of interest resides.Once the tip of LG arrives the chosen target, the bronchoscopist locksthe bronchoscope at the endotracheal tube by turning the screw/dial onBETLA until the bronchoscope is locked at the desired position, thenlocks the EWC at the orifice of the working channel on the bronchoscopeby existing devices and methods (described in “System of accessories foruse with bronchoscope” to Greenberg, Bet al., USPO U.S. Pat. No.8,663,088; USPO U.S. Pat. No. 8,317,149 to Greenburg B. et al. and PCTpatent application no, WO 03/086498 entitled “Endoscope Structure andTechniques for Navigation in Branched Structure” to Gilboa). Thebronchoscopist then removes the LG and inserts the tools of choice(biopsy forceps, aspiration needle, needle brush, fiducial or such),through the EWC to accomplish intended tasks (such as a biopsies of thelesion or the placement of the fiducial, etc.). After finishing up thelesion at right upper lobe, the bronchoscopist unlocks both BETLA andEWC/LG, repositions the bronchoscope to navigate to a new target atright middle lobe. This is achieved by loosening up the grip ofbronchoscope, and by adjusting the screw/dial on BETLA. A smooth drivingup and down till the bronchoscopist reaches the nearest point thebronchoscope allowed to the new target, and repeats the abovenavigational process with EWC/LG and places the LG tip to the closestpoint either near or on the new target, completes the intended tasks,e.g., biopsy of the lesion, placing of a fiducial mark. In case there isa need to remove the bronchoscope from the BETLA during procedure or atthe end of operation, the bronchoscopist can plug port A of the BETLA tomaintain the airtight integrity of ventilation system, to continueproviding mechanical ventilation until the patient is awake, and it issafe for the patient to be extubated to breathe on his own.

Using the BETLA is complimentary to existing devices, as thebronchoscopist is able to achieve complete control and maneuver ofbronchoscope and EWC, LG through the whole process without theassistance of others, i.e., the bronchoscopist can perform all of thesetasks: navigation, positioning, locking of bronchoscope byhimself/herself, except passing and receiving tools from supportingstaffs. Using the BETLA, the bronchoscopist overcomes a number ofsources of mechanical disturbance, such as the respiration of thepatient, the respiration of the bronchoscopist and the repeatedmaneuvers at the orifice of the EWC: changes of instruments, repeatedsampling, etc. These undesired and inevitable disturbances and theirresulting unintended movements of the bronchoscope, movements ordisplacements of the EWC tip away from the intended target, etc., can beeither completely stopped or significantly minimized by using the BETLA.

Using the BETLA provides and maintains an airtight seal of theventilator system during and after the operation, reduces the number ofpersonnel required, reduces human errors and gives the bronchoscopistthe total control of navigation, targeting, locking and adjusting thebronchoscope, and locking and adjusting the EWC and LG as desired. Useof the BETLA leads to a greater precision in accomplishing the intendedtasks, improves the diagnostic yield of bronchoscopic biopsies, deliverstherapeutic modality, such as fiducial, laser to a more precise targetlocation, and cuts down the existing operation cost.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

What is claimed is:
 1. A bronchoscopy/mechanical ventilation adaptor,the adaptor comprising: a body having a passageway; a mechanicalventilator access port configured to operatively couple a mechanicalventilator to the passageway; a bronchoscope access port configured toreceive a bronchoscope into the passageway, wherein the bronchoscopeaccess port comprises a reversibly adjustable inner diameter component;and an exit port configured to operatively connect the passageway to anendo tracheal tube.
 2. The adaptor according to claim 1, wherein thebronchoscope access port comprises an actuator configured to provide formechanical adjustment of the reversibly adjustable inner diametercomponent.
 3. The adaptor according to claim 2, wherein the actuatorcomprises a rotatable member.
 4. The adaptor according to claim 3,wherein the rotatable member is configured to rotate about thelongitudinal axis of the bronchoscope access port.
 5. The adaptoraccording to any of the preceding claims, wherein the reversiblyadjustable inner diameter component comprises a compressible member. 6.The adaptor according to claim 5, wherein the compressible member is acompressible tube.
 7. The adaptor according to any of claim 5 or 6,wherein the compressible member comprises a polymeric material.
 8. Theadaptor according to claim 7, wherein the polymeric material comprises asilicone or thermoplastic elastomer (TPE).
 9. The adaptor according toany of the preceding claims, wherein the reversibly adjustable innerdiameter component is configured to provide a magnitude of diameterchange ranging from 1 to 3.5 mm.
 10. The adaptor according to claim 9,wherein the reversibly adjustable inner diameter has an adjustablediameter that ranges from 3.5 to 7 mm.
 11. The adaptor according to anyof the preceding claims, wherein the adaptor is configured to beoperatively employed with a mammal.
 12. The adaptor according to claim11, wherein the mammal is a human.
 13. The adaptor according to any ofthe preceding claims, wherein the passageway ranges in length from 40 to50 mm.
 14. The adaptor according to any of the preceding claims, whereinthe bronchoscope access port and exit port are coaxial with thelongitudinal axis of the passageway.
 15. The adaptor according to claim14, wherein the mechanical ventilator port has a longitudinal accessthat is orthogonal to the longitudinal access of the passageway.
 16. Abronchoscopy method, the method comprising: providing a patientintubated with a tracheal tube operatively coupled to the exit port ofan adaptor according to any of claims 1 to 15; and introducing abronchoscope into the access port of the adaptor.
 17. The methodaccording to claim 16, wherein the method further comprises adjustingthe inner diameter of the reversibly adjustable inner diametercomponent.
 18. The method according to claim 16 or 17, wherein themethod further comprises imaging pulmonary tissue of the patient withthe bronchoscope.
 19. The method according to any of claims 16 to 18,wherein the method further comprises removing pulmonary tissue from thepatient via a working channel of the bronchoscope.
 20. The methodaccording to any of claims 16 to 19, wherein the method furthercomprises placing a therapeutic agent at a tissue location via a workingchannel of the bronchoscope.
 21. The method according to any of claims16 to 20, wherein the method further comprises producing a fiducial markat a tissue location via a working channel of the bronchoscope.
 22. Themethod according to any of claims 16 to 21, wherein the patient is amammal.
 23. The method according to claim 22, wherein the mammal is ahuman.